title: Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies.
abstract: OBJECTIVE
  To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period.
  
  
  METHODS
  Two randomized, double-masked, active-controlled, phase 3 trials.
  
  
  METHODS
  Two thousand four hundred fifty-seven patients with neovascular AMD.
  
  
  METHODS
  From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks.
  
  
  METHODS
  Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.
  
  
  RESULTS
  Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96.
  
  
  CONCLUSIONS
  All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.
authors.affiliation: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.affiliation: Department of Ophthalmology, Cole Eye Institute, Cleveland, Ohio.
authors.forename: Peter K
authors.initials: PK
authors.lastname: Kaiser
authors.affiliation: Department of Ophthalmology, Centre Hospitalier Universitaire de Bordeaux, Université Bordeaux 2, Bordeaux, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
authors.affiliation: Retina Consultants of Houston, Houston, Texas.
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.affiliation: Oxford Eye Hospital, University of Oxford, Oxford, United Kingdom.
authors.forename: Victor
authors.initials: V
authors.lastname: Chong
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Quan Dong
authors.initials: QD
authors.lastname: Nguyen
authors.affiliation: Wills Eye Hospital and Mid Atlantic Retina, Philadelphia, Pennsylvania.
authors.forename: Allen C
authors.initials: AC
authors.lastname: Ho
authors.affiliation: Department of Ophthalmology, Nagoya City University, Nagoya, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ogura
authors.affiliation: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Simader
authors.affiliation: Department of Ophthalmology, Duke University, Durham, North Carolina.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
authors.affiliation: Vitreous-Retina-Macula Consultants of New York, New York, New York.
authors.forename: Jason S
authors.initials: JS
authors.lastname: Slakter
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Yancopoulos
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Neil
authors.initials: N
authors.lastname: Stahl
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Yuhwen
authors.initials: Y
authors.lastname: Soo
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Majid
authors.initials: M
authors.lastname: Anderesi
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Sowade
authors.affiliation: Bayer HealthCare, Berlin, Germany; Universitatsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fur Augenheilkunde, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Christiane
authors.initials: C
authors.lastname: Norenberg
authors.affiliation: Bayer HealthCare, Berlin, Germany; Department of Neurology, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.affiliation: Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts. Electronic address: jsheier@eyeboston.com.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D000069579:Ranibizumab; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage* / Q000009:adverse effects; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D012160:Retina / Q000473:pathology; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D000069579:Ranibizumab